Known Crohn Disease SubjectsNCT01942720

Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

A study testing Capsule endoscopy and Ileocolonoscopy tests in people with Known Crohn Disease Subjects, run by Medtronic - MITG at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure Read more about this study

Who is it for?: Ages 2 to 75 years
Conditions the study is for: Known Crohn Disease Subjects
What is being tested?: Capsule endoscopy and Ileocolonoscopy tests
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 15 sitesUnited States
Study dates: Aug 2013to Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject ages 2-75 years, inclusive
Subjects with a diagnosis of known Crohn disease
Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)
Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.
Subject or parent agrees to sign consent form

Who cannot join

The presence of any of the following will exclude a subject from study enrollment:
Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE
Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
Stricture seen on radiological exam.
Indeterminate Colitis
Ulcerative Colitis

Show all 21Show fewer

Antibiotic Associated Colitis
Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment
Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.
Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
Subjects with known or suspected delayed gastric emptying
Subjects with known or suspected delayed Small bowel motility
Subject has any allergy or other known contraindication to the medications used in the study.
Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.
Unwillingness to use a medically accepted method of contraception throughout duration of study
Concurrent participation in another clinical trial using any investigational drug or device.
Subject has cardiac pacemaker or other implanted electromedical devices
Subject suffers from a life threatening condition.
Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Children's Center for Digestive Healthcare
Atlanta, Georgia
University of Maryland Medical Center
Baltimore, Maryland
UNC Chapel Hill
Chapel Hill, North Carolina
Gastroenterology Associates of Tidewater
Chesapeake, Virginia
Metropolitan Gastroenterology Group
Chevy Chase, Maryland
The University of Chicago
Chicago, Illinois
Iowa Digestive Disease Center
Clive, Iowa
Dr. Romeo, Dayton Gastroenterology
Dayton, Ohio, 45440
Indiana Unveresity Hospital
Indianapolis, Indiana
Borland-Groover Clinic
Jacksonville, Florida
Cedars Sinai Medical Center
Los Angeles, California
Digestive Health Center of Michigan
Michigan, Michigan
Atlantic Health System Morristown Memorial Pediatric GE
Morristown, New Jersey
Mayo Clinic
Scottsdale, Arizona
Shafran Gastroenterology Center
Winter Park, Florida

Other trials in United States

About this study

This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Read the detailed description

This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months .

Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\or adult subjects with known Crohn's disease

Conditions: Known Crohn Disease Subjects
Being tested: Capsule endoscopy and Ileocolonoscopy tests

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Capsule endoscopy and Ileocolonoscopy testsDevice

Study groups in NCT01942720
Study group	Role	What they receive
Capsule endoscopy	Other	Not described Receives: Device: Capsule endoscopy and Ileocolonoscopy tests

What is being measured

The primary outcome is the main question the study is designed to answer.

Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)
To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff
Measured: 6 months changefrom Baseline

Secondary outcomes (4)

Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes
Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline.
SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific
Measured: Baseline
Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum
Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff
Measured: 6 months change from Baseline
Evaluate the Entire SB CE Scores
Evaluate the entire SB CE Scores (Lewis \& CECDEIS) change as compared to the change at TI in CE Scores (Lewis \& CECDEIS).
Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific
Measured: 6 months change from Baseline
Adverse Events (AE)
To assess safety related to capsule retention and other adverse events
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jul 2016

First posted16 Sep 2013 (estimated)
Study startAug 2013
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Known Crohn Disease SubjectsStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01942720
Sponsor's protocol ID: MA-209
Status last verified: Aug 2016
First submitted: 11 Sep 2013
Last updated: 31 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Melmed GY, Dubinsky MC, Rubin DT, Fleisher M, Pasha SF, Sakuraba A, Tiongco F, Shafran I, Fernandez-Urien I, Rosa B, Papageorgiou NP, Leighton JA. Utility of video capsule endoscopy for longitudinal monitoring of Crohn's disease activity in the small bowel: a prospective study. Gastrointest Endosc. 2018 Dec;88(6):947-955.e2. doi: 10.1016/j.gie.2018.07.035. Epub 2018 Aug 4.
PubMed 30086261

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
ClinicalTrials.gov ID: NCT01942720
Acronym / sponsor ID: MA-209
Conditions: Known Crohn Disease Subjects
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 16 Sep 2013 (estimated)
Results: Posted 31 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Capsule endoscopy	Other	Device: Capsule endoscopy and Ileocolonoscopy tests

Who may qualify

Ages: 2 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Subject ages 2-75 years, inclusive
Subjects with a diagnosis of known Crohn disease
Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)
Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.
Subject or parent agrees to sign consent form

Key exclusion criteria (21 listed)

Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE
Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
Stricture seen on radiological exam.
Indeterminate Colitis
Ulcerative Colitis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Capsule endoscopy and Ileocolonoscopy tests	Device	Capsule endoscopy

Primary outcome

Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)
Time frame: 6 months changefrom Baseline
To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff

4 secondary outcomes

Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes
Time frame: Baseline
Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum
Time frame: 6 months change from Baseline
Evaluate the Entire SB CE Scores
Time frame: 6 months change from Baseline
Adverse Events (AE)
Time frame: 6 months

Results and safety

Results posted to the registry on 31 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Capsule Endoscopy	74	53

Primary outcome: Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)

Time frame: 6 months changefrom Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Capsule Endoscopy n = 54
PGA score change	-0.3 (0.77)
Total SB Lewis score	-382.9 (1232.8)
Total SB CECDEIS score change	-2.7 (9.05)

Capsule Endoscopy: Sperman correlation coeficient: -0.70, p = 0.631, Sperman test
Capsule Endoscopy: Sperman correlation coeficient: 0.022, p = 0.882, Sperman correlation

Population analysed: Correlation between changes in VCE mucosal scores (Lewis and CECDEIS) and change in PGA score of CD (Crohn's Disease) activity from baseline to follow-up at 6 months; number of participants for this outcome measure includes participants with available data for PGA, SB (small bowel) Lewis score, SB CECDEIS score, respectively

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data collected from subject enrollment up to end of study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Capsule Endoscopy	3 of 74 (4.1%)	24 of 74 (32.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30086261Melmed GY, Dubinsky MC, Rubin DT, Fleisher M, Pasha SF, Sakuraba A, Tiongco F, Shafran I, Fernandez-Urien I, Rosa B, Papageorgiou NP, Leighton JA. Utility of video capsule endoscopy for longitudinal monitoring of Crohn's disease activity in the small bowel: a prospective study. Gastrointest Endosc. 2018 Dec;88(6):947-955.e2. doi: 10.1016/j.gie.2018.07.035. Epub 2018 Aug 4.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan Leighton, MD principal investigator

Mayo Clinic

Gil Melmed, MD principal investigator

Cyder Cinai LA

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Capsule endoscopy and Ileocolonoscopy tests in people with Known Crohn Disease Subjects, run by Medtronic - MITG at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) (time frame: 6 months changefrom Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942720, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.